Status:
COMPLETED
Safety Study of the PrePex Device for Non-Surgical Adult Male Circumcision During Phased in National Implementation in an Effort to Prevent the Spread of HIV
Lead Sponsor:
Ministry of Health, Rwanda
Conditions:
Male Circumcision
Eligibility:
MALE
21-49 years
Phase:
NA
Brief Summary
It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision. Numerous papers on the top...
Detailed Description
Male circumcision can reduce the lifetime risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa. In 2009, the US Government (USAID) reported that scaling up male circumcision to r...
Eligibility Criteria
Inclusion
- Ages - 21 to 49 years
- Subject wants to be circumcised
- Uncircumcised
- Able to understand the study procedures and requirements
- Agrees to abstain sexual intercourse for 6 weeks post device removal
- Agrees to abstain from masturbation for 2 weeks post device removal
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 1 week post removal (2 weeks total)
- Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
- Subject agrees to anonymous video and photographs of the procedure and follow up visits
Exclusion
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes, by questionnaire
- Subject who have an abnormal penile anatomy or any penile diseases
- Subject that to the opinion of the investigator is not a good candidate
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT01921608
Start Date
January 1 2013
End Date
February 1 2013
Last Update
August 13 2013
Active Locations (1)
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1
Rwanda Military Hospital
Kigali, Rwanda